Greater Occipital Nerve and Cervical Region Injection in Patients With Trigeminal Neuralgia
Sponsor
Dr. Lutfi Kirdar Kartal Training and Research Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04505280
Collaborator
(none)
40
1
2
30
1.3
Study Details
Study Description
Brief Summary
The aim of this study is to investigate the efficacy of greater occipital nerve block and cervical injections with lidocaine
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
After being informed about the study and potantiel risks, all patients giving informed consent will undergo randomization in 1:1 ratio to 1% lidocaine or 0.9% saline groups
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Greater Occipital Nerve and Cervical Region Injection in Patients With Trigeminal Neuralgia
Actual Study Start Date
:
Jul 1, 2020
Anticipated Primary Completion Date
:
Oct 1, 2022
Anticipated Study Completion Date
:
Dec 30, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Active %1 lidocaine injections to greater occipital nerve and cervical region once a week for 4 weeks |
Drug: Lidocaine 1% Injectable Solution
Greater occipital nerve and cervical region injections once a week for 4 weeks
|
| Placebo Comparator: Placebo 0.9% saline injections to greater occipital nerve and cervical region once a week for 4 weeks |
Drug: Saline
0.9% saline Greater occipital nerve and cervical region injections once a week for 4 weeks
|
Outcome Measures
Primary Outcome Measures
- Efficacy on pain severity [3 months]
Efficacy on pain scores. Visual Analogue Scale (VAS). VAS is a ten-point scale where zero refers to no pain and ten refers to maximal pain
- Efficacy on pain frequency [3 months]
Pain frequency per day
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Classical Trigeminal Neuralgia
Exclusion Criteria:
- Secondary Trigeminal Neuralgia
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Afyonkarahisar University of Health Sciences | Afyonkarahisar | Kartal/Soğanlık | Turkey | 03217 |
Sponsors and Collaborators
- Dr. Lutfi Kirdar Kartal Training and Research Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Cem Bölük,
Principal Investigator,
Dr. Lutfi Kirdar Kartal Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT04505280
Other Study ID Numbers:
- 2011-KAEK-2
First Posted:
Aug 10, 2020
Last Update Posted:
Mar 22, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Cem Bölük,
Principal Investigator,
Dr. Lutfi Kirdar Kartal Training and Research Hospital
Additional relevant MeSH terms: